Clinical Trials Network
The Clinical Trials Network (CTN) is able to conduct rapid clinical trials to address public health-relevant immunization questions in large and specialized groups with a focus on safety, immunogenicity, and mechanisms of immunity. CTN includes sites in Vancouver, Calgary, Winnipeg, Hamilton, Toronto, Ottawa, Sudbury, Montreal, Quebec City, and Halifax.
The network completed a rapid Phase I study of the VSV-EBOV Ebola vaccine at the Halifax site in 2015-16, following an expedited grant application and review process during the Ebola outbreak. This phase 1 study was completed in <6 weeks, demonstrating CTN’s strong rapid research response capacity.
A second study assessed the need for a Hepatitis B booster dose in adolescence for jurisdictions with infant immunization programs. Protection of mid-teens was satisfactory, but continued protection into adulthood is less certain following infant versus adolescent immunization. Ongoing evaluation in adults is needed.
A multicenter rapid clinical trial of a 4CMenB vaccine was also conducted in adolescents and young adults (age 17-26) to assess the immunogenicity, reactogenicity and tolerability of a compressed schedule as would be desirable in an outbreak (0, 3 weeks vs. 0, 2 months). Pain at the injection site and muscles aches were highest after the first (unblinded) dose. Systemic muscle aches, drowsiness and nausea were common after both doses. Fever was not common and AEFI did not interfere with study completion (120/121 participants completed the immunizations). Complete immunogenicity results were received in July 2017 and the results are being analyzed.
A phase 1 study of a novel CMV vaccine is testing safety and immunogenicity in 108 participants; follow-up will be completed in August 2017.
The Pharmacists as Immunizers study is a prospective CTN study of the effectiveness of targeted patient interventions by pharmacists on vaccine coverage, compared to control communities, measured using de-identified pharmacy database information, physician vaccine reports, and vaccine doses delivered. This 2-year study began in November 2016 and focuses on communities in NS and New Brunswick.
In preparation for expected clinical studies of a vaccine to prevent invasive Haemophilus influenzae type a (Hia) disease in Indigenous communities, we initiated studies to determine burden of disease, Hia immunoepidemiology, and knowledge, attitudes, beliefs, and behaviors about Hia disease among Indigenous communities in Northern Ontario. Engagement with Indigenous communities is a central focus of this work. The study is just beginning work on salivary IgG and IgA ELISAs, with data analysis to begin in September 2017.
The Ebola-NML study is a 3-year NIH-led PHAC-funded study in Winnipeg of pre-exposure prophylaxis (PREP) in people at increased risk of occupational (laboratory, clinical or field work) exposure to Ebola virus. Participants receive a dose of VSV-Ebola and are randomized to a booster or no booster at 18 months. The study has Health Canada approval and will start screening in September 2017.
CTN also embarked on its first African-Canadian collaboration with a phase II Ebola vaccine in HIV-affected populations study (ACHIV-Ebola). This international collaboration between the International Development Research Centre (IDRC), CIRN and Merck, with sites in Africa (Senegal, Burkina Faso) and Canada (Montreal, Ottawa), will evaluate the safety and tolerability of the VSV-Ebola vaccine in HIV-infected adults and adolescents; enrollment will begin in August 2017.